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The Anterior Cervical Plate System is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications; degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Anterior Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter-length combination. Plates are available in a variety of lengths.

This document is a 510(k) premarket notification for a medical device called the Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding AI/algorithm performance, detailed study design, and expert review is not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This was a bench testing study, not a clinical study with patient data. The "sample size" would refer to the number of physical constructs tested, but this specific number is not provided, only that the "worst case" construct was tested.
• Data Provenance: Not applicable. This refers to bench test results in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was a mechanical bench test against a standard, not a study requiring expert clinical ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set to adjudicate.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/algorithm-driven device. It is a physical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/algorithm-driven device.

7. The type of ground truth used

• Mechanical Performance Standards: The ground truth for performance was established by recognized mechanical testing standards (ASTM F1717) and comparison to the predicate device's established performance.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-driven device. There is no "training set."

9. How the ground truth for the training set was established

• Not applicable.

Summary of the Study:

The study proving the device meets the acceptance criteria was a bench testing study. The purpose of this study was to demonstrate substantial equivalence of the Anterior Cervical Plate System to a legally marketed predicate device (Synthes Anterior CSLP System, K030866).

• Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the mechanical performance of the subject device, when tested according to ASTM F1717 (covering static compression bending, torsion, and dynamic compression bending), would be comparable or equivalent to the predicate device.
• Device Performance: The study reported that "The mechanical test results demonstrated that the Subject device is substantially equivalent to the predicate devices."
• Test Conduct: The testing was performed on the "worst case Anterior Cervical Plate construct."
• Ground Truth: The "ground truth" for the mechanical performance comparison was the established performance characteristics of the predicate device and the requirements of the ASTM F1717 standard.
• Purpose: The overall conclusion was that the Anterior Cervical Plate System has the same intended use, identical indications for use, similar technological characteristics and materials as its predicate(s), and minor differences do not raise new safety or efficacy concerns after bench testing.

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The DeGen Medical Hyper-C Anterior Cervical Plate system is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Hyper-C Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with following indications:
• Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spinal Stenosis
• Trauma (i.e. fracture or dislocation)
• Deformity or curvatures (including scoliosis, kyphosis, or lordosis)
• Spinal Tumors
• Pseudoarthrosis or failed previous fusion
• Spondylolisthesis
• Decompression of the spine following total or partial cervical vertebrectomy

The DeGen Medical Hyper-C Anterior Cervical Plate Systems consists of cervical plates and bone screws. All implants are intended to provide stabilization of the cervical vertebrae. The HACP provides anterior fixation from either fixed or variable angle construct in self-tapping or self-drilling bone screw options.

The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text describes a 510(k) premarket notification for a medical device called the "Hyper-C Anterior Cervical Plate System." This document is a regulatory approval letter and a summary of the device, not a study report demonstrating the device meets specific acceptance criteria through clinical or AI performance metrics.

Therefore, I cannot extract the information required to answer your questions as they pertain to the evaluation of an AI/ML-driven device or a medical imaging study. The document explicitly states:

• Non-Clinical Performance Testing Conclusion: "Non-clinical testing was performed to demonstrate the DeGen Medical Hyper-C Anterior Cervical Plate System (HACP) is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed: Static and dynamic compression testing per ASTM F1717, Static torsion testing per ASTM F1717, Screw strength via ASTM F543, Push-out testing for Locking Screws."

This indicates that the device's performance was evaluated through mechanical and material testing (non-clinical), not studies involving image analysis, AI algorithms, human readers, or clinical outcomes that would generate the kind of data you're asking for.

The questions you've posed (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are highly relevant for the assessment of AI/ML-enabled medical devices, especially those involved in diagnostic imaging or similar analytical tasks. However, the Hyper-C Anterior Cervical Plate System is a physical orthopedic implant, and its approval is based on demonstrating substantial equivalence to existing devices primarily through mechanical integrity and biocompatibility, as outlined in the non-clinical testing section.

In summary, the provided document does not contain the information needed to answer your questions because it describes the regulatory clearance of a physical medical implant, not an AI/ML diagnostic or image analysis system.

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The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:

• instability caused by trauma or fracture; .
• instability associated with correction of cervical lordosis and kyphosis deformity; ●
• . instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
• instability associated with major reconstructive surgery for primary tumors or metastatic . malignant tumors of the cervical spine;
• instability associated with single or multiple level corpectomy in advanced degenerative . · disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal canal stenosis and cervical myelopathy.

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Reliance Anterior Cervical Plate System device is intended to be used as an anterior cervical plate device. The Reliance Anterior Cervical Plate System is comprised of implant and instrument components. The Reliance Anterior Cervical Plate implant device is manufactured from Titanium alloy as specified by ASTM F-136. The Reliance Anterior Cervical Plate is a combination of the plate, cover plate, set screw, and bone screw components. The cover plate is attached to the plate by means of the set screw.

1. Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The provided document describes mechanical and other non-clinical performance testing. It does not mention a "test set" in the context of clinical data, human subjects, or data provenance from specific regions. The testing was conducted on samples of the Reliance Anterior Cervical Plate System itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This was a non-clinical performance study involving mechanical testing and assessments of material properties, not a study requiring expert clinical review to establish ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth. This document describes non-clinical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a spinal implant, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical implant, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this performance study was established through standardized mechanical testing protocols (ASTM F-1717) and assessments of material properties (sterilization, biocompatibility). The comparison was made against the performance of legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This document describes non-clinical performance testing of a physical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as no training set for a machine learning model was used.

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The inViZia™ Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.

The inViZia™ Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The inViZia 10 Anterior Cervical Plate System is a temporary implant system used to facilitate the biological process of spinal fusion. This system consists of plates, screws and instruments and is intended for anterior use in the cervical spine. Surgical instruments are provided to facilitate placement of the implants.

The implants consist of plates of varying length, fixed and variable screws of varying diameter and length. Components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

This system is intended to provide stabilization until a solid spinal fusion develops. The system may then be removed, per the surgeon's discretion.

The Zimmer Spine inViZia Anterior Cervical Plate System is a temporary implant system for spinal fusion.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:

The document describes in vitro mechanical testing rather than a study involving human subjects or patient data. Therefore, there isn't a "test set" in the traditional sense of patient data. The "samples" would refer to the physical devices or components tested. The document does not specify the exact number of devices or components tested for each mechanical test.

• Data Provenance: Not applicable in the context of in vitro mechanical testing. The testing was conducted according to recognized ASTM standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth for mechanical performance in this context is established by adherence to recognized industry standards (ASTM F-1717:2010), which are developed by experts in the field of materials science and medical device testing, but not in the sense of clinicians establishing a "diagnosis" or "outcome" as ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication method" relates to human interpretation of data, which is not relevant for in vitro mechanical testing against a standard. The results of the mechanical tests would be assessed directly against the pass/fail criteria of the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is a physical spinal implant, not an AI-powered diagnostic or therapeutic system that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical spinal implant.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating device performance is based on engineering standards and mechanical testing specifications (ASTM F-1717:2010). This standard defines the expected mechanical properties and performance characteristics for spinal implant devices.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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The King Cobra™ Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The King Cobra™ Cervical Plate System consists of self-tapping screws and plates. Screws are available in a variety of diameter- length combinations. Plates are available in a variety of lengths.

The provided text describes the "King Cobra™ Cervical Plate System" and its substantial equivalence to a predicate device, rather than an AI/ML device. Therefore, the questions related to AI/ML specific aspects like acceptance criteria for algorithmic performance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable here.

However, I can extract the information related to the device's technical characteristics and the study performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, "acceptance criteria" often refer to performance standards met through specific tests. In this case, the device is a spinal plate system, and its performance is evaluated against mechanical testing standards. The acceptance criterion is that the device performs "as well as or better than the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a "sample size" in the context of human data or test sets. The performance data is based on mechanical testing of the "worst case King Cobra™ construct." The specific number of constructs tested is not detailed.
• Data Provenance: Not applicable as this is mechanical testing of a medical device, not a study involving human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable as this is mechanical testing of a medical device, not a study establishing ground truth with expert review.

4. Adjudication Method

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a mechanical medical device, not an AI/ML system or diagnostic tool typically evaluated with such studies.

6. Standalone Performance Study (Algorithm Only)

• Not applicable as this is a mechanical medical device.

7. Type of Ground Truth Used

• The "ground truth" for the mechanical performance was established by ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), which is an industry standard for mechanical testing of spinal implants. The comparison was against the performance of a predicate device.

8. Sample Size for the Training Set

• Not applicable as this is a mechanical medical device, not an AI/ML model that requires training data.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

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The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-11) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications:

· Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

• · Failed previous fusion

The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.

The provided text describes the 510(k) summary for the "Active Anterior Cervical Plate System" (K073500), a medical device intended for spinal fixation. This submission focuses on establishing substantial equivalence to previously marketed predicate devices, primarily through mechanical performance testing and comparison of technological characteristics.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical data or patient samples. The evaluation of this device is based on mechanical performance attributes per ASTM F1717. For such testing, the "sample size" would refer to the number of devices or components tested. This information is not provided in the given text.

Similarly, the data provenance (country of origin, retrospective/prospective) is not applicable as the study described is a mechanical engineering test, not a clinical study involving human subjects or their data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for mechanical testing is typically established by the specifications of the ASTM F1717 standard and the results of the physical tests themselves. It does not involve human expert consensus in the way clinical studies do.

4. Adjudication Method for the Test Set

This is not applicable for mechanical performance testing. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies in evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This information is not applicable. The submission describes a spinal fixation system, which is a physical implant, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily mechanical performance standards (ASTM F1717). The device's performance was compared to existing predicate devices based on these standards.

8. The Sample Size for the Training Set

This information is not applicable as the evaluation is based on mechanical performance testing, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Summary of the Study and Device Performance:

The study described for the Active Anterior Cervical Plate System is largely a technical and mechanical performance evaluation to demonstrate substantial equivalence to legally marketed predicate devices. The primary "study" involved:

• Comparison of Technological Characteristics: The device's features (augmenting stability, segmented plate for screw translation, use of titanium alloys, compression application) were compared and found to be substantially equivalent to features present in various predicate devices.
• Mechanical Testing per ASTM F1717: The device underwent mechanical performance testing according to the ASTM F1717 standard. The results of this testing demonstrated that its mechanical attributes were "substantially equivalent" to those of the predicate devices.

The FDA's review concluded that the device is substantially equivalent to predicate devices for its stated indications for use, primarily based on these comparative analyses and mechanical testing. No clinical studies with human participants, expert consensus for diagnosis, or AI performance evaluations are mentioned in this 510(k) summary.

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The IST Anterior Cervical Plate is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• Degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
• Spondvlolisthesis .
• Trauma (i.e., fractures or dislocations) .
• Tumors .
• Deformity (defined as kyphosis, lordosis, or scollosis) .
• Pseudoarthrosis .
• Failed previous fusions .

The IST Anterior Cervical Plate is made of titanium alloy. The plate is offered in various lengths to meet individual patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The provided text describes a medical device, the IST Anterior Cervical Plate System, and its 510(k) submission (K072650) to the FDA. The submission focuses on substantial equivalence to predicate devices rather than a standalone clinical study proving specific performance metrics against an acceptance criterion.

Therefore, the information traditionally found in a comprehensive acceptance criteria study (like those for AI/Software as a Medical Device - SaMD) is not present in this document. This submission relies on performance data based on mechanical testing.

Based on the provided text, the direct answers to your questions are as follows:

1. A table of acceptance criteria and the reported device performance

Explanation: In this 510(k) submission, the "acceptance criteria" for the device's performance are implicitly tied to demonstrating substantial equivalence through mechanical testing according to a recognized standard (ASTM F1717). There are no specific numerical clinical performance metrics (e.g., sensitivity, specificity, accuracy) defined in this document that the device had to meet. The performance reported is that it met the ASTM F1717 standard, indicating mechanical equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission primarily relies on mechanical testing, not a clinical test set with patient data. Therefore, there is no "test set" in the context of patient data, sample size for such a set, or data provenance. The "testing" refers to mechanical properties in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As there is no clinical test set with patient data, there was no need for experts to establish ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Without a clinical test set requiring expert interpretation or labeling, there is no adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical implant (Anterior Cervical Plate System), not an AI/software device designed to assist human readers. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For mechanical testing, the "ground truth" is defined by the physical standards and measurement methodologies outlined in ASTM F1717, which determine material properties and performance under stress. It does not involve clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

Summary of this particular 510(k) submission: This 510(k) for the IST Anterior Cervical Plate System is a traditional submission for a physical medical implant. It primarily relies on mechanical testing (ASTM F1717) to demonstrate substantial equivalence to existing predicate devices. It does not involve clinical trials with patient data, AI algorithms, or human-in-the-loop performance studies. Therefore, many of the questions related to clinical performance, ground truth, and AI-specific evaluations are not applicable to the information provided in this document.

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